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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Cutaneous
510(k) Number K853552
Device Name SENTRY FLEXIBLE TENS
Applicant
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Correspondent
Sentry Medical Products, Inc.
2615 S. Orange Ave.
Santa Ana,  CA  92704
Regulation Number882.1320
Classification Product Code
GXY  
Date Received08/26/1985
Decision Date 09/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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